COVID-19Phase 1/2NCT04383574

Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19)

A Phase 1/2 study testing Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 in people with COVID-19, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 422 participants
Where: 1 siteChina
Study dates: 22 May 2020to 31 May 2022
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adults aged ≥60 years;
Be able to understand and sign the informed consent voluntarily;
Provide legal identification;

Who cannot join

Travel / residence history of Wuhan city and surrounding areas or other communities with case reports within 14 days prior to the enrolment;
Contact with SARS-CoV-2 infected persons (positive for nucleic acid detection) within 14 days prior to the enrolment;
Contact patients with fever or respiratory symptoms from Wuhan city and surrounding areas, or from communities with case reports within 14 days prior to the enrolment;
Two or more cases of fever and / or respiratory symptoms in a small contact area of subjects, such as family, office, school class or other places within 14 days prior to the enrolment;
History of SARS;
History of SARS-CoV-2 infection;

Show all 22Show fewer

History of asthma, allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
Autoimmune disease or immunodeficiency / immunosuppression;
Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
Serious nervous system disease (epilepsy, convulsion or convulsion) or psychosis;
Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
Long history of alcohol or drug abuse;
Receipt of blood products in the past 3 months;
Receipt of other investigational drugs in the past 30 days;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
According to the investigator's judgment, the subject has any other factors that are not suitable for the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Renqiu City Center for Disease Control and Prevention
Renqiu, Hebei, 062550

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cell), in Healthy Elderly Aged 60 Years and Above

This study is a randomized, double-blinded, and placebo controlled phase 1\&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy elderly aged 60 years and above.

Read the detailed description

This study is a randomized, double-blinded, single-center, placebo-controlled phase 1\&2 clinical trial in healthy elderly aged 60 years and above. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 422 subjects will be enrolled, with 72 in phase 1 and 350 in phase 2. 72 Subjects with 36 in medium-dosage group and 36 in high-dosage group in phase 1 will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and the subjects at each dosage group will be assigned in a 2:1 ratio to receive investigational vaccine or placebo respectively.All enrolled subjects will receive 1 dose of booster immunization 1 year after primary immunization.350 Subjects in phase 2 will receive two doses of primary immunization according to the immunization schedule of day 0,28,the subjects will be assigned in a ratio of 2:2:2:1 to receive the low dosage, medium dosage, high dosage vaccine, or placebo. All enrolled subjects will received 1 dose of booster immunization(the third dose ) 6 months after primary immunization.And subjects in medium-dosage group and high -dosage group will receive the second booster dose (the fourth dose) 1 year after the second dose.

Conditions: COVID-19
Being tested: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of placebo at the schedule of day 0,28, Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28Biological
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (600SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28Biological
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of high dosage (1200SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (1200SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.
Two doses of placebo at the schedule of day 0,28Biological
The placebo was manufactured by Sinovac Research \& Development Co., Ltd., Two doses of placebo at the schedule of day 0,28,and one dose of booster immunization with placebo 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28Biological
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of low dosage (300SU/0.5ml)experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with low dosage (300SU/0.5ml) experimental vaccine 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.

Study groups in NCT04383574
Study group	Role	What they receive
Experimental Vaccine-medium dosage	Experimental	24 participants in medium-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in medium-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose ) and the second booster dose (the fourth dose) 1 year after the second dose. Receives: Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Experimental Vaccine-high dosage	Experimental	24 participants in high-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in high-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose) and the second booster dose (fourth dose) 1 year after the second dose . Receives: Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Placebo	Placebo comparator	24 participants including 12 at medium dosage stage and 12 at high dosage in phase Ⅰ will receive two doses of placebo according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 50 participants in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization. Receives: Biological: Two doses of placebo at the schedule of day 0,28
Experimental Vaccine-low dosage	Experimental	100 participants at low dosage stage in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization. Receives: Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety index-incidence of adverse reactions
Incidence of adverse reactions after each dose vaccination
Measured: Day 0-28 after each dose vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
The seroconversion rate of neutralizing antibody 28 days after the second dose vaccination.
Measured: 28 days after the second dose vaccination

Secondary outcomes (5)

Safety index-incidence rate of adverse reactions
Incidence rate of adverse reactions within 7 days after each dose vaccination
Measured: within 7 days after each dose vaccination
Safety index-incidence rate of serious adverse events in phase Ⅰ
Incidence rate of SAEs from the beginning of the vaccination to 6 months after the booster immunization in phase Ⅰ
Measured: From the beginning of the vaccination to 6 months after the booster immunization
Safety index-incidence rate of serious adverse events in phase Ⅱ
Incidence rate of SAEs from the beginning of the vaccination to 12 months after the booster immunization vaccination in phase Ⅱ
Measured: From the beginning of the vaccination to 12 months after the booster immunization vaccination
Immunogenicity index-seropositive rate, GMT, and GMI of neutralizing antibodies
The seropositive rate, GMT, and GMI of neutralizing antibodies 28 days after the second dose vaccination;
Measured: 28 days after the second dose vaccination
Immunogenicity index-seroconversion rate, seropositive rate, GMT, and GMI in phase Ⅰ
The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the first dose vaccination in phase Ⅰ
Measured: 28 days after the first dose vaccination in phase Ⅰ

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 202031 May 2022

First posted12 May 2020
Study start22 May 2020
Primary completion28 Dec 2021
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 422 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04383574
Sponsor's protocol ID: PRO-nCOV-1002
Status last verified: Jul 2021
First submitted: 9 May 2020
Last updated: 11 Aug 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Xin Q, Wu Q, Chen X, Han B, Chu K, Song Y, Jin H, Chen P, Lu W, Yang T, Li M, Zhao Y, Pan H, Yu H, Wang L. Six-month follow-up of a booster dose of CoronaVac in two single-centre phase 2 clinical trials. Nat Commun. 2022 Jun 3;13(1):3100. doi: 10.1038/s41467-022-30864-w.
PubMed 35660738
Zeng G, Wu Q, Pan H, Li M, Yang J, Wang L, Wu Z, Jiang D, Deng X, Chu K, Zheng W, Wang L, Lu W, Han B, Zhao Y, Zhu F, Yu H, Yin W. Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials. Lancet Infect Dis. 2022 Apr;22(4):483-495. doi: 10.1016/S1473-3099(21)00681-2. Epub 2021 Dec 8.
PubMed 34890537
Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, Li M, Jin H, Cui G, Chen P, Wang L, Zhao G, Ding Y, Zhao Y, Yin W. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3.
PubMed 33548194

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cell), in Healthy Elderly Aged 60 Years and Above
ClinicalTrials.gov ID: NCT04383574
Acronym / sponsor ID: PRO-nCOV-1002
Conditions: COVID-19
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 422 participants (actual)
Lead sponsor: Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
Study start: 22 May 2020 (actual)
Primary completion: 28 Dec 2021 (actual)
Study completion: 31 May 2022 (actual)
First posted: 12 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Experimental Vaccine-medium dosage	Experimental	Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,2824 participants in medium-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in medium-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose ) and the second booster dose (the fourth dose) 1 year after the second dose.
Experimental Vaccine-high dosage	Experimental	Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,2824 participants in high-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in high-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose) and the second booster dose (fourth dose) 1 year after the second dose .
Placebo	Placebo comparator	Biological: Two doses of placebo at the schedule of day 0,2824 participants including 12 at medium dosage stage and 12 at high dosage in phase Ⅰ will receive two doses of placebo according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 50 participants in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
Experimental Vaccine-low dosage	Experimental	Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28100 participants at low dosage stage in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy adults aged ≥60 years;
Be able to understand and sign the informed consent voluntarily;
Provide legal identification;

Key exclusion criteria (22 listed)

Travel / residence history of Wuhan city and surrounding areas or other communities with case reports within 14 days prior to the enrolment;
Contact with SARS-CoV-2 infected persons (positive for nucleic acid detection) within 14 days prior to the enrolment;
Contact patients with fever or respiratory symptoms from Wuhan city and surrounding areas, or from communities with case reports within 14 days prior to the enrolment;
Two or more cases of fever and / or respiratory symptoms in a small contact area of subjects, such as family, office, school class or other places within 14 days prior to the enrolment;
History of SARS;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (600SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.	Biological	Experimental Vaccine-medium dosage
Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of high dosage (1200SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (1200SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.	Biological	Experimental Vaccine-high dosage
Two doses of placebo at the schedule of day 0,28The placebo was manufactured by Sinovac Research \& Development Co., Ltd., Two doses of placebo at the schedule of day 0,28,and one dose of booster immunization with placebo 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.	Biological	Placebo
Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of low dosage (300SU/0.5ml)experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with low dosage (300SU/0.5ml) experimental vaccine 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.	Biological	Experimental Vaccine-low dosage

Primary outcome

Safety index-incidence of adverse reactions
Time frame: Day 0-28 after each dose vaccination
Incidence of adverse reactions after each dose vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
Time frame: 28 days after the second dose vaccination
The seroconversion rate of neutralizing antibody 28 days after the second dose vaccination.

5 secondary outcomes

Safety index-incidence rate of adverse reactions
Time frame: within 7 days after each dose vaccination
Safety index-incidence rate of serious adverse events in phase Ⅰ
Time frame: From the beginning of the vaccination to 6 months after the booster immunization
Safety index-incidence rate of serious adverse events in phase Ⅱ
Time frame: From the beginning of the vaccination to 12 months after the booster immunization vaccination
Immunogenicity index-seropositive rate, GMT, and GMI of neutralizing antibodies
Time frame: 28 days after the second dose vaccination
Immunogenicity index-seroconversion rate, seropositive rate, GMT, and GMI in phase Ⅰ
Time frame: 28 days after the first dose vaccination in phase Ⅰ

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
Derived from this study: PubMed 35660738Xin Q, Wu Q, Chen X, Han B, Chu K, Song Y, Jin H, Chen P, Lu W, Yang T, Li M, Zhao Y, Pan H, Yu H, Wang L. Six-month follow-up of a booster dose of CoronaVac in two single-centre phase 2 clinical trials. Nat Commun. 2022 Jun 3;13(1):3100. doi: 10.1038/s41467-022-30864-w.
Derived from this study: PubMed 34890537Zeng G, Wu Q, Pan H, Li M, Yang J, Wang L, Wu Z, Jiang D, Deng X, Chu K, Zheng W, Wang L, Lu W, Han B, Zhao Y, Zhu F, Yu H, Yin W. Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials. Lancet Infect Dis. 2022 Apr;22(4):483-495. doi: 10.1016/S1473-3099(21)00681-2. Epub 2021 Dec 8.
Derived from this study: PubMed 33548194Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, Li M, Jin H, Cui G, Chen P, Wang L, Zhao G, Ding Y, Zhao Y, Yin W. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuliang Zhao, Master principal investigator

Hubei Provincial Center for Disease Control and Prevention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety index-incidence of adverse reactions (time frame: Day 0-28 after each dose vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04383574, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.